The Modified Vaccine Ankara (MVA), the first vector-based AIDS vaccine will be tested in India and the trials are expected to commence before March 2004. The preventive AIDS vaccine that counters the HIV subtype C, most prevalent in India is being developed at the Pune’s National AIDS Research Institute. Preparations are also on now for the Phase 2 and Phase 3 trials at the same Institute.
Giving details on the AIDS research vaccine programme in India, Vijay L Mehta, programme director, Applied Vaccine Research said that Phase I and Phase II are safety trials where the safety of the vaccine on the humans will be tested. In phase I, MVA will be tested on 20-40 volunteers who do not have the virus. Phase II trials will also be on the unaffected group. But Phase III will be on 200-3000 patients who are in the high risk category.
The earlier vaccine that under went animal trails faced a hurdle as the HIV virus is not present in animals. Now the latest version of the vaccine that is under development is a multigenic- made of gene and protein parts rather than the viral vaccine developed from a weakened version of a whole virus, he said.
US-based Therion Biologicals Inc is manufacturing the multigenic recombinant MVA-based AIDS vaccine for the trials. If the vaccine is found promising then in the Phase I trials there will be a transfer of technology from US to an Indian manufacturer to produce the vaccine for Phase II and Phase III trials.
MVA is planned through a memorandum of understanding signed between the International AIDS Research Initiative and the government of India.
The approval process may also prove a challenge, as the plan evolved to test the vaccine has to be submitted to the national regulatory authorities before it moves in the first stage of trials on human beings.
Dr. Jean- Louis, director International AIDS Research Initiative said that more than 10,000 HIV infected volunteers had taken part in clinical trials going on the various parts of the world. HIV preventive vaccine trials were going on in developing countries, including China, Thailand, Brazil, Uganda, Kenya, Cuba and Botswana.
The overall AIDS vaccine development process, including clinical trials from Phase I to Phase III would take 7-10 years before accessibility could be ensured. The Phase II would generate safety data to ascertain whether the vaccine induces the appropriate immune response while Phase III would be an efficacy trial, he informed.
On the scene in Karnataka, Vandana Gurnani, project director, Karnataka State AIDS Prevention Society (KSAPS) said that Karantaka is one of the six high AIDS prevalence states in the country. Between 1987 and 2003 the KSAPS detected 1,790 cases here. North Karnataka, coastal Karnataka, Bangalore and Mysore are high HIV prevalence districts. While there are 19 Sentinel Surveillance Sites in Karnataka for HIV/AIDS monitoring of people at STD clinics, antenatal clinics and in the intravenous drug user group, it would be scaled up to 66 sites by 2003 end at all the 27 district headquarters in Karnataka.
Anjali Nayyar, country director, International AIDS Vaccine Initiative (IAIV) on the sidelines of the first state level interactive session for Karnataka, she said similar meetings have been held in Maharashtra, Andhra Pradesh and Tamil Nadu and other states with the high prevalence of AIDS.
The meeting is aimed at developing a sustained long-term partnership with the society on the community-based preparedness for the AIDS vaccine.